Testing the Reward-Drinker Hypothesis of Naltrexone Using an Extended-Release Formulation
Recruiting
18-65 years
All
Phase
4
60 participants needed
1 Location
Brief description of study
This
study is being conducted to compare the effects of a medication
(extended-release naltrexone or XR-NTX) or placebo (an inactive substance)
together with brief counseling on reducing or stopping drinking.
XR-NTX
is approved by the U.S. Food and Drug Administration (FDA) for treating alcohol
dependence. Its use is experimental in the treatment of alcohol dependence in people
whose primary reason for drinking alcohol is to obtain its rewarding effects
(“reward drinkers”).
Participants will be
compensated/reimbursed for their time and effort. Participants may be
compensated up to $345 if they are eligible to participate and complete all
study visits.
Detailed description of study
This
is a 7 visit study to occur over 12 weeks. This includes an initial screening
visit, an 8-week treatment phase (during which time you will receive 2
injections at 4-week intervals of XR-NTX or a placebo), and a follow-up visit 4
weeks after the treatment phase. We expect to enroll a total of 60 people in
the study. A summary of the visits is below:
1) Screening
visit to determine your eligibility (~3 hours)
2) 1st
Study Drug Visit at week 1 (~1.5 hours)
3) 3 bi-weekly
visits at weeks 2, 4, and 6 (~1 hour each)
4) Endpoint
visit at week 8 (~ 1 hour)
5) Follow-up
visit, 4 weeks after endpoint visit (~1 hour)
To participate in this study, you must be:
1) 18-65 years old
2) express a desire to reduce or stop drinking
3) able to complete all study visits and willing to receive 2 injections of study medication over 8 weeks of treatment.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
-
Conditions:
alcohol,alcohol use disorder,addictions
-
Age: Between 18 Years - 65 Years
-
Gender: All
Updated on
09 Mar 2024.
Study ID: 849558
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